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. 2016 Oct;6(5):409-416.
doi: 10.21037/cdt.2016.03.09.

Meta-analysis of randomized controlled trials on efficacy and safety of extended thienopyridine therapy after drug-eluting stent implantation

Wenyi Tang  1 , James Yeh  2 , Jian Chen  1 , Mao Liu  1 , Jianting Ke  3 , Guangyi Tan  1 , Xiufang Lin  1 , Wei Wu  1
Affiliations

Meta-analysis of randomized controlled trials on efficacy and safety of extended thienopyridine therapy after drug-eluting stent implantation

Wenyi Tang et al. Cardiovasc Diagn Ther. 2016 Oct.

Abstract

Background: The potential benefits and risks of extended thienopyridine therapy beyond 12 months after drug-eluting stent (DES) implantation remain unclear.

Methods: Randomized controlled trials (RCTs) were searched in PubMed, EMBASE, the Cochrane Library and China National Knowledge Infrastructure databases. The adverse clinical endpoints were compared between 12 months group (aspirin alone) and >12 months group (additional thienopyridine plus aspirin after 12-month dual antiplatelet therapy). Odds ratios (ORs) with 95% confidence intervals (95% CIs) were used as summary statistics. A random-effect model was used in the meta-analysis process.

Results: Finally, three RCTs incorporating 16,265 participants were included in this meta-analysis. The results indicated that the incidences of myocardial infarction (1.55% vs. 2.90%; OR =0.58; 95% CI, 0.40-0.84; P=0.004) and stent thrombosis (0.32% vs. 0.98%; OR =0.35; 95% CI, 0.20-0.62; P<0.001) in the >12 months group were significantly lower than the 12 months group. However, compared to the 12 months group, the extended thienopyridine therapy markedly increased the risk of bleeding events (2.09% vs. 1.28%; OR =1.64; 95% CI, 1.23-2.17; P<0.001). The risks of stroke (0.78% vs. 0.84%; P=0.67) and cardiac death (0.94% vs. 0.89%; P=0.61) were similar between the two groups.

Conclusions: The synthesis of available evidence indicates that a regimen of extended thienopyridine therapy beyond 12 months may significantly reduce the risks of myocardial infarction and stent thrombosis but increase the risk of bleeding events in the patients who have received DESs implantation.

Keywords: Drug-eluting stents (DESs); dual antiplatelet therapy; thienopyridine.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Flow diagram of the systematic review process.
Figure 2
Figure 2
Forest plot illustrating the risk of myocardial infarction: 12 months group vs. >12 months group.
Figure 3
Figure 3
Forest plot illustrating the risk of stent thrombosis: 12 months group vs. >12 months group.
Figure 4
Figure 4
Forest plot illustrating the risk of death: 12 months group vs. >12 months group.
Figure 5
Figure 5
Forest plot illustrating the risk of stroke: 12 months group vs. >12 months group.
Figure 6
Figure 6
Forest plot illustrating the risk of bleeding events: 12 months group vs. >12 months group.
Figure S1
Figure S1
Funnel plots of the included studies.
Figure S2
Figure S2
Forest plot illustrating the risk of death/myocardial infarction/Stroke: 12 months group vs. >12 months group.
Figure S3
Figure S3
Forest plot illustrating the risk of death/myocardial infarction: 12 months group vs. >12 months group.
Figure S4
Figure S4
Forest plot illustrating the risk of net clinical outcome: 12 months group vs. >12 months group. Net clinical outcome was a composite of any death, myocardial infarction, stent thrombosis, stroke, repeat revascularization and major bleeding events.
Figure S5
Figure S5
Forest plot illustrating the risk of definite stent thrombosis: 12 months group vs. >12 months group.
Figure S6
Figure S6
Forest plot illustrating the risk of Repeat revascularization: 12 months group vs. >12 months group.
Figure S7
Figure S7
Forest plot illustrating the risk of ischemic stroke: 12 months group vs. >12 months group.
Figure S8
Figure S8
Forest plot illustrating the risk of major bleeding: 12 months group vs. >12 months group.
Figure S9
Figure S9
Forest plot illustrating the risk of minor bleeding: 12 months group vs. >12 months group.
See this image and copyright information in PMC

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